NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial

Active Not RecruitingNA

Sponsor: Vanderbilt-Ingram Cancer Center

Conditions: Stage I Lung Cancer, Stage II Lung Cancer

Interventions: Cryosurgery, Robotic Bronchoscopy, Bronchoscopy with Biopsy, Resection, Chest Radiography

Countries: United States

This clinical trial studies side effects and best treatment time of cryodevitalization in treating patients with early stage (stage I or stage II) lung cancer. Cryodevitalization is a type of cryosurgery that uses a flexible probe (cryoprobe) to kill tumor cells by freezing them. It is delivered at the time of standard diagnostic robotic bronchoscopy. Using cryodevitalization may be safe, tolerable and/or effective in treating patients with early stage lung cancer.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients with a single pulmonary nodule with a size less than or equal to three centimeters (average long and short axis) confirmed as malignant intraprocedurally (rapid on-site evaluation with pathology assessment showing lung cancer or oligometastatic disease) without evidence of mediastinal involvement who require nodule biopsy prior to proceeding with surgical resection
* Nodules must be located in the outer 2/3 of the periphery of the lung, greater than 10 mm from the pleura and from large blood vessels or mediastinal structures to avoid injury to other visceral organs
* Patients deemed to have a surgical resection treatment option based on preoperative staging computed tomographic (CT), postoperative predicted forced expiratory volume in 1 second (FEV1) \> 40% and evaluation of medical comorbidities after discussion at multidisciplinary tumor board
* Age \> 18 years old

Exclusion Criteria:

* Target nodule is within the International Association for the Study of Lung Cancer (IASLC) "central zone" (including bronchial tree, major vessels, heart, esophagus, spinal cord and phrenic \& laryngeal nerves), or are \< 10 mm from the pleura
* Patients with an expected survival less than 6 months
* Patients with endobronchial lesions, concerning for malignancy, visualized during the initial bronchoscopic evaluation of the airways
* Patients with medically uncorrectable coagulopathy: abnormal platelet count \< 100 × 10\^9/L or an international normalized ratio \> 1.5
* Patients with known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \> 50mmHg)
* Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors
* Patients with medical comorbidities deemed high-risk for surgical resection
* Pregnant women
* Inability to provide informed consent

Locations (1)

Nashville, Tennessee, United States